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Patent protection is critical in the highly competitive world of biotechnology. To that end, the goal, the mission, the quest of many patent practitioners simply is to get a patent issued from the U.S. Patent and Trademark Office. But many attorneys, in-house counsel included, who practice before patent offices around the world often lose sight of whether the patent claims sought can withstand the subsequent aggressive attack that will be made if the patent ever is asserted against another party in litigation. Overcoming patent office rejections and getting claims allowed is not the end game. Too many times lawyers overestimate the value of the statutory presumption of validity afforded to issued patents. As recent cases demonstrate, it does not shield the patent and provide the protection some would think. Moreover, the clear and convincing burden of proof that defendants must meet to prove invalidity of a patent is sometimes not as difficult to establish as one might think, especially when the patentee has overreached to obtain broad claims. The question that should be examined by a company’s decision-maker on litigation — be it the general counsel or the business group leader — is can the patent survive the courtroom? The mandate to obtain allowance of the broadest claim possible is rudimentary in patent practice. Lawyers learn this from the first reading of John L. Landis’ “Mechanics of Patent Claim Drafting” and throughout their training in obtaining (i.e. “prosecuting”) patents. In the field of biotechnology, that lesson is especially important in instances in which the inventions being patented are worthy of pioneering status and, thus merit broad claims if the written description supports such claims. Having said that, the real discovery described in many biotech patents is, more times than not, limited and simply cannot support broad claims. In fact, the federal district courts and the U.S. Court of Appeals for the Federal Circuit have invalidated a startling number of biotech patents for failing to meet the written description requirement and/or for lack of enablement of the full scope of the claims. The Federal Circuit in Regents of the University of California v. Eli Lilly and Co. (1997) invalidated a patent attempting to cover the production of human insulin because the patent only provided an adequate written description of rat DNA. In Plant Genetic Systems, N.V. v. DEKALB Genetics Corp. (2003), the Federal Circuit held that claims to all plants were invalid because they failed to enable persons of skill in the art to utilize the technology for all plant species, in particular, the entire category of monocotyledons. In Enzo Biochem Inc. v. Calgene Inc. (1999), the U.S. District Court for the District of Delaware held two patents directed to antisense technology not enabled for the full scope of the claims and the Federal Circuit affirmed. In Genetech v. NovoNordisk (1997), the Federal Circuit held claims to a process of making human growth hormone invalid because undue experimentation would be required to make and use the invention as claimed. PATENT’S FATE? Does this mean invalidation is the fate awaiting all biotech patents that become the subject of a complaint filed in the federal courts? No. It is possible for biotechnology patents to survive the courtroom if the patent claims are 1. “not too wide” as they say; 2. adequately supported by the written disclosure; and 3. meet the other requirements for patentability. For example, in 2001′s Bio-technology General Corp. v. Genentech Inc., the Federal Circuit reversed the district court’s holding of invalidity for lack of enablement. Also in Amgen Inc. v. Hoeschst Marion Roussel Inc. (2003), the Federal Circuit found that patent claims of properly tailored breadth were valid. If the patent claims are narrowly drafted to claim a particular DNA sequence disclosed in the patent specification, then there generally should not be any issue with meeting the enablement or written description requirements. But knowing the rules by which to abide is not always easy. In Enzo Biochem Inc. v. Gen-Probe (2002), the Federal Circuit affirmed the district court’s finding that the patent’s composition claims failed to meet the written description requirement when the patentee made a deposit of the biological material. The initial decision by the court came as quite a shock because the justification for deposits of biological material was in the first instance to comply with the written description requirement. A deposit of biological material makes the contents accessible to the public when not otherwise available in written form. The patent office promulgated rules for the procedural requirements of such deposits in 1988. In view of that history and recognizing the importance of biological deposits to patent practice, the Federal Circuit on rehearing vacated its prior decision and remanded to the district court. Enzo demonstrates again the uncertainties that exist when biotech patents enter the courtroom. Deposits of biological materials have become routine for purposes of meeting the written description requirement. Suddenly, after the trial and on appeal, what was once taken for granted was no longer reliable. As biotech patents continue to be tested in the courtroom, other trends may change. To what extent does the art of biotechnology remain unpredictable? Techniques and procedures once unimaginably difficult and time-consuming now are routine laboratory procedures. What was once indescribable now can be described in words. Those issues remain to be decided. But in most every case, surviving the courtroom will depend upon keeping the scope of the claim within sight of the patent disclosure. Susan Knoll is a partner in the intellectual property practice of the Houston office of Howrey Simon Arnold & White (www.howrey.com). Knoll’s practice includes all aspects of intellectual property law, with an emphasis in patent and trade secret litigation. She is a frequent lecturer nationally and internationally on IP issues. If you are interested in submitting an article to law.com, please click here for our submission guidelines.

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